Quantitative and qualitative profiles of a multi-component medicine, particularly, preparations made from naturally-occurring substances such as a Kampo preparation change according to geological factors, ecological factors, the time, place, and age of collection, weather during growing period, and the like of the raw material herbals to be used. Therefore, a standard for evaluating the qualities, safety, effect, and the like of multi-component medicines such as Kampo preparations is specified, based on which such medicines are evaluated by national regulatory authorities, chemical organizations, manufacturers, and the other organizations concerned.
However, the standard for evaluating the qualities and the like of a multi-component medicine are generally prepared based on the content and the like of one or more appropriately selected components characteristic to the multi-component medicine.
For example, Gekkan Yakuji, vol. 28, No. 3, pp. 67-71 (1986) describes that when an essential component of a multi-component medicine cannot be identified, two or more components, having physical properties undergoing quantitative analysis, which are easily soluble in water, not decomposed in hot water, and chemically unreactive with other components are selected and their content is chemically analyzed to employ the resultant values as a standard of evaluation.
On the other hand, a method of analyzing a multi-component medicine using chromatography to obtain ultraviolet-visible absorption spectroscopy for each elution time (hereafter referred to as “fingerprint data”) and preparing a standard based on the component information has been known. For example, JP-A-2002-14215 describes a method of evaluating a multi-component medicine by selecting several peaks among fingerprint data and converting the fingerprint data into a bar-code.
However, since the specific component is quantitatively analyzed based on the concept of “content of a specific component” or “peaks of chromatogram of a specific component” in this method, waveform processing by a computer operation is necessary in order to separate the peaks of a specific component from the peaks of other components on a chromatogram and to determine the peak area and height of the specific component. This has been one of the causes of impairment of the accuracy of the data. That is, since there is no reproducibility in a strict sense in the elution time of a peak, there have been dispersion in the results of the waveform processing of the peaks. The dispersion is particularly remarkable when processing a waveform with small and broad peaks or continuous peaks. The method thus lacks reliability as an evaluation method. Furthermore, a considerable amount of time is required for waveform processing using a computer.
Moreover, since the amount of information (the number of data points) is limited to the number of peaks of a specific component in this method, the amount of information cannot be freely increased or decreased and the data processing time cannot be controlled. There is a case in which an optimal evaluation method cannot be established.
Furthermore, because the contents of two or more specific components are obtained as two or more values according to the above-mentioned method, it is necessary to synthesize and judge those values. It has been impossible to evaluate a multi-component medicine using a single numerical value. Namely, it is impossible to indicate how one multi-component medicine to be evaluated differs from a group of multi-component medicines by using a single numerical value.
Therefore, a method for evaluating a multi-component medicine which is almost free from dispersion of data and highly reliable, requires only a short data processing time, and can evaluate the multi-component medicine using a single numerical value has been desired.